Lasik Device To Correct Bifocal Vision Approved
Advanced Medical Optics Inc. claims the invention is the first Lasik device to correct one of a patient's eyes to see far (myopia) and the other eye to see objects close-up (presbyopia).
According to the FDA the instrument works by correcting all the nearsightedness to help distance vision in a patient's dominant eye, while fixing only part of the nearsightedness in the less dominant eye, which helps close-up vision. The FDA has asked the company to conduct a study tracking 500 patients for six months after surgery, to check for potential visual disturbances that could limit activities or worsen a patient's quality of life.
According to Daniel Shultz, director of the FDA's Center for Devices and Radiological Health, the device will reduce the need for reading glasses for adults 40 and older, who have laser in-situ keratomileusis surgery to correct distance vision.
The surgery encompasses a procedure in which the surgeon cuts a flap in the outer layer of the cornea in order to remove a small amount of tissue. The flap is then replaced. According to the FDA, patients considering the CustomVue Monovision LASIK surgery should first wear monovision contact lenses to determine whether they can tolerate having one eye under-corrected.
The surgery permanently changes the cornea, and side effects may include sensitivity to bright lights. These may be visual disturbances such as halos around lights and night-driving glare. Other potential side effects include double vision and visual fluctuation.